KRS 217.5402: Manufacturer of investigational drug, biological product, or device may

make it available to a requesting patient eligible under KRS 217.5401 to

217.5408.

(1) A manufacturer of an investigational drug, biological product, or device may make

the investigational drug, biological product, or device available to an eligible patient

who has requested it pursuant to KRS 217.5401 to 217.5408.

(2) The manufacturer may:

(a) Provide an investigational drug, biological product, or device to an eligible

patient without receiving compensation; or

(b) Require an eligible patient to pay the costs of or the costs associated with the

manufacture of the investigational drug, biological product, or device.

(3) A manufacturer shall not be required to make an investig ational drug, biological

product, or device available to an eligible patient.